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NCT00824265 · ClinicalTrials.gov registry record · Phase 3
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
NCT00824265: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00824265 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 365 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00824265, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Primary Outcome
PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of t
Interventions
- DRUG OFC Infusion
- DRUG FC infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2009-03-12 |
| Est. Completion | 2017-10-25 |
| Phase | Phase 3 |
What the finished NCT00824265 record still lists
NCT00824265 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which OFC Infusion is the first listed.
NCT00824265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00824265 about?
NCT00824265 is a clinical study titled "Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia". The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
What is the current status of trial NCT00824265?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2009-03-12. Estimated completion is 2017-10-25.
What interventions are being tested in trial NCT00824265?
The interventions under investigation include: OFC Infusion (DRUG), FC infusion (DRUG).
Who is sponsoring clinical trial NCT00824265?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00824265's enrollment target sits among peer trials
365 1001st of 2000 higher than 998 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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